NCT01093443

Brief Summary

In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 11, 2010

Status Verified

November 1, 2009

Enrollment Period

6 months

First QC Date

March 24, 2010

Last Update Submit

October 8, 2010

Conditions

Infertility

Keywords

IVFICSIGnRH antagonistpretreatment

Outcome Measures

Primary Outcomes (1)

  • Endocrine profile

    The purpose is to assess the endocrine profile in each treatment group

    up to 9 months

Secondary Outcomes (1)

  • Pregnancy rate

    up to 9 months

Study Arms (2)

A

PLACEBO COMPARATOR

Patients undergo a standard treatment with a classical GnRH antagonist protocol.

Drug: ovarian stimulation

B

ACTIVE COMPARATOR

Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days

Drug: ovarian stimulation

Interventions

ovarian stimulationDRUG

rFSH with GnRH antagonists

A

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< 39 years old on day of randomisation
  • FSH \< 12 (in the early follicular phase)
  • Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
  • Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
  • BMI between 18 and 29 (both inclusive)
  • st or 2nd trial
  • IVF or ICSI
  • Randomisation at out-patient clinic

You may not qualify if:

  • ≥ 39 years old on day of randomisation
  • Endometriosis ≥ grade 3
  • PCOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

Ovulation Induction

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 11, 2010

Record last verified: 2009-11

Locations

BE(1)